The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Bichat Hospital
Paris, France
Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
The patient will evaluate the level of leakage under the skin protector after each removal of pouch. A 4 scale level will be used: * "no leakage under the skin protector", * "leakage under the skin protector not soiling clothes", * "leakage under the skin protector soiling clothes", * "sudden and massive leakage under the skin protector".
Time frame: Up to one day for closed pouches and up to two days for drainable pouches.
Assessment of the condition of peristomal skin
Time frame: At V1 and V2 protocol visits (at day 0 and day 14)
Acceptability of each pouch
Acceptability is defined by those criteria: Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance
Time frame: At each protocol visit (day 0, day 14 and day 28)
Preference between Flexima® Active and Sensura®
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Assessment of the quality of life with Stoma-QoL questionnaire
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Adverse(s) Event(s)
Time frame: At each protocol visits (at day 0, day 14 and day 28)
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